Trial Outcomes & Findings for Assisted Fluid Management IDE Study (NCT NCT03469570)
NCT ID: NCT03469570
Last Updated: 2024-11-08
Results Overview
Stroke volume change meeting the clinician-selected fluid strategy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
330 participants
Primary outcome timeframe
30 Day follow-up
Results posted on
2024-11-08
Participant Flow
Participant milestones
| Measure |
Assisted Fluid Management
EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature: Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
|
|---|---|
|
Overall Study
STARTED
|
330
|
|
Overall Study
COMPLETED
|
307
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
Baseline characteristics by cohort
| Measure |
Assisted Fluid Management
n=330 Participants
EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature: Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
|
|---|---|
|
Age, Continuous
|
66 years
n=314 Participants • Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
|
|
Sex: Female, Male
Female
|
131 Participants
n=314 Participants • Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
|
|
Sex: Female, Male
Male
|
183 Participants
n=314 Participants • Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
|
|
Race/Ethnicity, Customized
Rance and Ethnicity · Asian
|
2 Participants
n=314 Participants • Measure Analysis Population Description: Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
|
|
Race/Ethnicity, Customized
Rance and Ethnicity · African American
|
22 Participants
n=314 Participants • Measure Analysis Population Description: Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
|
|
Race/Ethnicity, Customized
Rance and Ethnicity · White
|
284 Participants
n=314 Participants • Measure Analysis Population Description: Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
|
|
Race/Ethnicity, Customized
Rance and Ethnicity · Other
|
5 Participants
n=314 Participants • Measure Analysis Population Description: Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
|
|
Race/Ethnicity, Customized
Rance and Ethnicity · Not Reported
|
1 Participants
n=314 Participants • Measure Analysis Population Description: Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
|
PRIMARY outcome
Timeframe: 30 Day follow-upStroke volume change meeting the clinician-selected fluid strategy
Outcome measures
| Measure |
Assisted Fluid Management
n=314 Participants
EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature: Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
|
|---|---|
|
Effectiveness of the Assisted Fluid Management Feature
|
307 Participants
|
Adverse Events
Assisted Fluid Management
Serious events: 88 serious events
Other events: 226 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Assisted Fluid Management
n=314 participants at risk
EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature: Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.64%
2/314 • 9 Months
|
|
Cardiac disorders
Arrhythmia
|
1.6%
5/314 • 9 Months
|
|
General disorders
Asthenia
|
0.32%
1/314 • 9 Months
|
|
General disorders
Complication associated with device
|
0.64%
2/314 • 9 Months
|
|
General disorders
Oedema
|
0.32%
1/314 • 9 Months
|
|
General disorders
Pain
|
0.32%
1/314 • 9 Months
|
|
General disorders
Pyrexia
|
0.96%
3/314 • 9 Months
|
|
Hepatobiliary disorders
Biliary colic
|
0.32%
1/314 • 9 Months
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Abdominal infection
|
0.64%
2/314 • 9 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.32%
1/314 • 9 Months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
3/314 • 9 Months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.32%
1/314 • 9 Months
|
|
Cardiac disorders
Syncope
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Colites
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Haematemesis
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.96%
3/314 • 9 Months
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Malaena
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
2/314 • 9 Months
|
|
Infections and infestations
Abscess
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Bacteraemia
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Device related sepsis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Diverticulitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Gangrene
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Graft infection
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Osteomyelitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Pancreatic abscess
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Peritonitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Pneumonia
|
0.64%
2/314 • 9 Months
|
|
Infections and infestations
Purulent discharge
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Pyelonephritis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Scrotal infection
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Sepsis
|
2.5%
8/314 • 9 Months
|
|
Infections and infestations
Streptococcal infection
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Urinary tract infection
|
0.96%
3/314 • 9 Months
|
|
Infections and infestations
Wound infection
|
3.2%
10/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
1.3%
4/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Cement embolism
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Peripancreatic fluid collection
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.96%
3/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.64%
2/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Stoma site discomfort
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Stoma site ischaemia
|
0.32%
1/314 • 9 Months
|
|
Investigations
Blood culture positive
|
0.32%
1/314 • 9 Months
|
|
Investigations
Oxygen saturation decreased
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.64%
2/314 • 9 Months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.32%
1/314 • 9 Months
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.32%
1/314 • 9 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Encephalopathy
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Intracranial hypotension
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Somnolence
|
0.32%
1/314 • 9 Months
|
|
Product Issues
Device occlusion
|
0.32%
1/314 • 9 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
8/314 • 9 Months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.32%
1/314 • 9 Months
|
|
Renal and urinary disorders
Urinary retention
|
0.32%
1/314 • 9 Months
|
|
Renal and urinary disorders
Vesical fistula
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.96%
3/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.96%
3/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.96%
3/314 • 9 Months
|
|
Surgical and medical procedures
Abscess drainage
|
0.32%
1/314 • 9 Months
|
|
Vascular disorders
Deep vein thrombosis
|
1.3%
4/314 • 9 Months
|
|
Vascular disorders
Distributive shock
|
0.32%
1/314 • 9 Months
|
|
Vascular disorders
Haematoma
|
1.3%
4/314 • 9 Months
|
|
Vascular disorders
Hypotension
|
1.3%
4/314 • 9 Months
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.32%
1/314 • 9 Months
|
|
Vascular disorders
Peripheral ischaemia
|
0.32%
1/314 • 9 Months
|
|
Vascular disorders
Shock haemorrhagic
|
0.32%
1/314 • 9 Months
|
|
Vascular disorders
Venous thrombosis
|
0.32%
1/314 • 9 Months
|
Other adverse events
| Measure |
Assisted Fluid Management
n=314 participants at risk
EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature: Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.5%
55/314 • 9 Months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.2%
7/314 • 9 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.64%
2/314 • 9 Months
|
|
Cardiac disorders
Arrhythmia
|
4.1%
13/314 • 9 Months
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/314 • 9 Months
|
|
Cardiac disorders
Cardiac arrest
|
0.64%
2/314 • 9 Months
|
|
Cardiac disorders
Sinus bradycardia
|
0.32%
1/314 • 9 Months
|
|
Cardiac disorders
Syncope
|
0.32%
1/314 • 9 Months
|
|
Cardiac disorders
Tachycardia
|
2.2%
7/314 • 9 Months
|
|
Eye disorders
Diplopia
|
0.32%
1/314 • 9 Months
|
|
Eye disorders
Eye Swelling
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Ascites
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Colitis
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Constipation
|
1.3%
4/314 • 9 Months
|
|
Gastrointestinal disorders
Crohn's disease
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
6/314 • 9 Months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Flatulence
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Haematemesis
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Haematochezia
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Ileus paralytic
|
2.2%
7/314 • 9 Months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.3%
4/314 • 9 Months
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Lower gastrointestinal perforation
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Melaena
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Nausea
|
3.8%
12/314 • 9 Months
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.64%
2/314 • 9 Months
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.32%
1/314 • 9 Months
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
13/314 • 9 Months
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.32%
1/314 • 9 Months
|
|
General disorders
Asthenia
|
0.32%
1/314 • 9 Months
|
|
General disorders
Catheter site ischaemia
|
0.32%
1/314 • 9 Months
|
|
General disorders
Complication associated with device
|
0.96%
3/314 • 9 Months
|
|
General disorders
Hypothermia
|
0.32%
1/314 • 9 Months
|
|
General disorders
Infusion site extravasation
|
0.32%
1/314 • 9 Months
|
|
General disorders
Oedema
|
4.1%
13/314 • 9 Months
|
|
General disorders
Pain
|
0.96%
3/314 • 9 Months
|
|
General disorders
Pyrexia
|
1.9%
6/314 • 9 Months
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.32%
1/314 • 9 Months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.32%
1/314 • 9 Months
|
|
Hepatobiliary disorders
Biliary colic
|
0.32%
1/314 • 9 Months
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Abdominal infection
|
0.64%
2/314 • 9 Months
|
|
Infections and infestations
Abscess
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Bacteraemia
|
1.6%
5/314 • 9 Months
|
|
Infections and infestations
Bacterial disease carrier
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Bronchitis viral
|
0.32%
1/314 • 9 Months
|
|
General disorders
Tenderness
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Cellulitis
|
0.64%
2/314 • 9 Months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Device related sepsis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Diverticulitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Gangrene
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Graft infection
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Oesophageal candidiasis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Oral candidiasis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Osteomyelitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Otitis media
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Pancreatic abscess
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Peritonitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Pneumonia
|
2.5%
8/314 • 9 Months
|
|
Infections and infestations
Purulent discharge
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Pyelonephritis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Pyuria
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Scrotal infection
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Sepsis
|
2.9%
9/314 • 9 Months
|
|
Infections and infestations
Septic Shock
|
0.00%
0/314 • 9 Months
|
|
Infections and infestations
Sinusitis
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Streptococcal infection
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Urinary tract infection
|
3.5%
11/314 • 9 Months
|
|
Infections and infestations
Viral diarrhoea
|
0.32%
1/314 • 9 Months
|
|
Infections and infestations
Wound infection
|
4.5%
14/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
1.6%
5/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Cement embolism
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
3.8%
12/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.64%
2/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
0.64%
2/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Peripancreatic fluid collection
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
9.6%
30/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
4.1%
13/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
1.3%
4/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.3%
4/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.64%
2/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Stoma site discomfort
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Stoma site extravasation
|
0.64%
2/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Stoma site ischaemia
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.32%
1/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.64%
2/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.32%
1/314 • 9 Months
|
|
Investigations
Blood bicarbonate increased
|
0.32%
1/314 • 9 Months
|
|
Investigations
Blood bilirubin increased
|
0.32%
1/314 • 9 Months
|
|
Investigations
Blood creatinine increased
|
0.64%
2/314 • 9 Months
|
|
Investigations
Blood culture positive
|
0.32%
1/314 • 9 Months
|
|
Investigations
Cholangiogram
|
0.32%
1/314 • 9 Months
|
|
Investigations
Enterococcus test positive
|
0.32%
1/314 • 9 Months
|
|
Investigations
Haematocrit decreased
|
0.32%
1/314 • 9 Months
|
|
Investigations
Haemoglobin decreased
|
0.64%
2/314 • 9 Months
|
|
Investigations
Oxygen saturation decreased
|
0.64%
2/314 • 9 Months
|
|
Investigations
Transaminases increased
|
0.00%
0/314 • 9 Months
|
|
Investigations
Troponin increased
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.96%
3/314 • 9 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
2/314 • 9 Months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.64%
2/314 • 9 Months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Electrolyte depletion
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.64%
2/314 • 9 Months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.96%
3/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.96%
3/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.64%
2/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.32%
1/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
5/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.64%
2/314 • 9 Months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.64%
2/314 • 9 Months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.64%
2/314 • 9 Months
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.3%
4/314 • 9 Months
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/314 • 9 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.64%
2/314 • 9 Months
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.32%
1/314 • 9 Months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.32%
1/314 • 9 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.32%
1/314 • 9 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.64%
2/314 • 9 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Akinesia
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.64%
2/314 • 9 Months
|
|
Nervous system disorders
Chronic inflammatory demyelinating
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Dizziness
|
0.64%
2/314 • 9 Months
|
|
Nervous system disorders
Dysarthria
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Encephalopathy
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Headache
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Hemiparesis
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Hypoaesthesia
|
0.64%
2/314 • 9 Months
|
|
Nervous system disorders
Intracranial hypotension
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Myoclonus
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Sciatica
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Somnolence
|
0.32%
1/314 • 9 Months
|
|
Nervous system disorders
Syncope
|
0.32%
1/314 • 9 Months
|
|
Product Issues
Device leakage
|
0.32%
1/314 • 9 Months
|
|
Product Issues
Device occlusion
|
0.64%
2/314 • 9 Months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/314 • 9 Months
|
|
Psychiatric disorders
Depression
|
0.32%
1/314 • 9 Months
|
|
Psychiatric disorders
Hallucination
|
0.32%
1/314 • 9 Months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/314 • 9 Months
|
|
Psychiatric disorders
Mental status changes
|
0.32%
1/314 • 9 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
13.7%
43/314 • 9 Months
|
|
Renal and urinary disorders
Bladder spasm
|
0.32%
1/314 • 9 Months
|
|
Renal and urinary disorders
Haematuria
|
0.32%
1/314 • 9 Months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.64%
2/314 • 9 Months
|
|
Renal and urinary disorders
Oliguria
|
0.32%
1/314 • 9 Months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.32%
1/314 • 9 Months
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
14/314 • 9 Months
|
|
Renal and urinary disorders
Vesical fistula
|
0.32%
1/314 • 9 Months
|
|
Reproductive system and breast disorders
Ovarian vein thrombosis
|
0.32%
1/314 • 9 Months
|
|
Reproductive system and breast disorders
Penile pain
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.64%
2/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.2%
10/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.64%
2/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
7/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.64%
2/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.96%
3/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.96%
3/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.32%
1/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
7/314 • 9 Months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.32%
1/314 • 9 Months
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.32%
1/314 • 9 Months
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.32%
1/314 • 9 Months
|
|
Surgical and medical procedures
Abdominal cavity drainage
|
0.32%
1/314 • 9 Months
|
|
Surgical and medical procedures
Abscess drainage
|
0.32%
1/314 • 9 Months
|
|
Surgical and medical procedures
Biliary drainage
|
0.32%
1/314 • 9 Months
|
|
Surgical and medical procedures
Nephrostomy
|
0.32%
1/314 • 9 Months
|
|
Surgical and medical procedures
Vascular catheterisation
|
0.32%
1/314 • 9 Months
|
|
Surgical and medical procedures
Wound drainage
|
0.64%
2/314 • 9 Months
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
6/314 • 9 Months
|
|
Vascular disorders
Distributive shock
|
0.32%
1/314 • 9 Months
|
|
Vascular disorders
Haematoma
|
1.6%
5/314 • 9 Months
|
|
Vascular disorders
Hypertension
|
2.5%
8/314 • 9 Months
|
|
Vascular disorders
Hypotension
|
12.1%
38/314 • 9 Months
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.32%
1/314 • 9 Months
|
|
Vascular disorders
Peripheral ischaemia
|
0.64%
2/314 • 9 Months
|
|
Vascular disorders
Shock haemorrhagic
|
0.32%
1/314 • 9 Months
|
|
Vascular disorders
Venous thrombosis
|
0.64%
2/314 • 9 Months
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.32%
1/314 • 9 Months
|
Additional Information
Edwards Critical Care Clinical Affairs
Edwards Lifesciences
Phone: (949) 250-7169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place